Dataset Information

The Treatment of Anxiety in Autism Spectrum Disorder (TAASD) Study: Rationale, Design and Methods.

ABSTRACT: This paper describes the rationale, design, and methods of the Treatment for Anxiety in Autism Spectrum Disorders study, a three-site randomized controlled trial investigating the relative efficacy of a modular CBT protocol for anxiety in ASD (Behavioral Interventions for Anxiety in Children with Autism) versus standard CBT for pediatric anxiety (the Coping Cat program) and a treatment-as-usual control. The trial is distinct in its scope, its direct comparison of active treatments for anxiety in ASD, and its comprehensive approach to assessing anxiety difficulties in youth with ASD. The trial will evaluate the relative benefits of CBT for children with ASD and investigate potential moderators (ASD severity, anxiety presentation, comorbidity) and mediators of treatment response, essential steps for future dissemination and implementation.

SUBMITTER: Kerns CM

PROVIDER: S-EPMC5523838 | biostudies-other | 2016 Jun

REPOSITORIES: biostudies-other

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Publications

The Treatment of Anxiety in Autism Spectrum Disorder (TAASD) Study: Rationale, Design and Methods.

Kerns Connor M CM Wood Jeffrey J JJ Kendall Philip C PC Renno Patricia P Crawford Erika A EA Mercado Rogelio J RJ Fujii Cori C Collier Amanda A Hoff Alexandra A Kagan Elana R ER Small Brent J BJ Lewin Adam B AB Storch Eric A EA

Journal of child and family studies 20160206 6

This paper describes the rationale, design, and methods of the Treatment for Anxiety in Autism Spectrum Disorders study, a three-site randomized controlled trial investigating the relative efficacy of a modular CBT protocol for anxiety in ASD (Behavioral Interventions for Anxiety in Children with Autism) versus standard CBT for pediatric anxiety (the <i>Coping Cat</i> program) and a treatment-as-usual control. The trial is distinct in its scope, its direct comparison of active treatments for anx ...[more]

PMID: 28747814

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Project description:OBJECTIVE:To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. METHODS:Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. RESULTS:CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CONCLUSIONS:CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. TRIAL REGISTRATION:ClinicalTrials.gov NCT00052078.

Dataset Information

The Treatment of Anxiety in Autism Spectrum Disorder (TAASD) Study: Rationale, Design and Methods.

Publications

The Treatment of Anxiety in Autism Spectrum Disorder (TAASD) Study: Rationale, Design and Methods.

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